Health TrialsbyHealthPanel

Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

ConditionsOpioid-use DisorderOpioid Use, UnspecifiedBuprenorphine Dependence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSenthil Sadhasivam

About this trial

The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age greater 18 years

Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.

Pregnant with single baby

Planned delivery at Methodist, University or Riley Hospital

Disqualifiers

Serious maternal medical illness as deemed by study physician or investigator.

Known or suspected major fetal/neonatal congenital abnormalities.

Trial population

Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Subutex / Buprenorphine

    Drug

    Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.

  • Fetal & Neonatal MRI

    Diagnostic test

    Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.

  • DNA/Genetic/Pharmacokenetic Blood Draws

    Diagnostic test

    Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Pregnant Mothers with Opioid Use Disorder3 interventions
Group B: Pregnant Mothers2 interventions

Trial outcomes

Primary outcomes

1

Incidence of opioid misuse severity using assessments

Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D.

Time frame
5 years
2

Pharmacological treatment for neonatal abstinence syndrome

Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.

Time frame
5 years

Secondary outcomes

1

Incidence of adverse effects of buprenorphine using MRI

Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.

Time frame
5 years
2

Concentration of long-term neurodevelopmental outcomes using assessments

Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Senthil Sadhasivam

Lead sponsor

University of Pittsburgh

Sponsor institution

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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